This document provides an introduction to validation in the pharmaceutical industry. It discusses the origins and need for validation to ensure quality and control costs. The document outlines the key types of validation: prospective, retrospective, concurrent and revalidation. It also describes the scope of validation, noting it requires appropriate infrastructure, documentation, personnel and management involvement. Validation should be performed for facilities, equipment, utilities, processes and when major changes occur to demonstrate consistency in producing products that meet specifications.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
Definition
Scope of calibration
Scope of validation
Frequency of calibration
Importance/ purpose of calibration
Importance/ advantages of validation
Difference between calibration & validation
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
A brief introduction of validation concept, its scope, advantage. Types of validation, stages of validation, Consideration in principle of validation. Prerequisites of validation, validation protocol, process validation, strategy of process validation of solid dosage form, validation report.
Analytical method validation.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
This presentation was made to solely for students to make them aware/ understand basics of “Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
complete and detail study on the topic of validation used in pharmaceuticals industry and also in the learning purpose for the students in the classrooms. this ppt help a lot to the students as well as teachers to learn more on the validation topics.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...
Introduction and scope of validation
1. Presented by,
Jahnabi Sarmah
Dept. of pharmacy
M. Pharm 1st sem
INTRODUCTION AND SCOPE
OF VALIDATION
1
Guided by,
Dr. Ananta Choudhuri
Associate professor
Dept. of pharmacy
2. CONTENT:
2
• Introduction
• Need for validation
• Types of validation:
Prospective validation (or premarket validation)
Retrospective validation
Concurrent validation
Revalidation
• Scope of validation
• Reference
3. INTRODUCTION:
• The concept of validation was first proposed by two Food
and Drug Administration (FDA) officials.
• Byers and Bud Loftus, in the mid 1979s in(USA )order to
improve the quality of pharmaceuticals. It was proposed in
direct response to several problems in the sterility of large
volume parenteral market.
• The first validation activities were focused on the
processes involved in making these products, but quickly
spread to associated processes including environmental
control, media fill, equipment sanitization and purified
water production.
3
4. INTRODUCTION:
• Validation is the process of establishing documentary
evidence demonstrating that a procedure, process, or
activity carried out in testing and then production
maintains the desired level of compliance at all stages.
• In the pharmaceutical industry, it is very important that in
addition to final testing and compliance of products, it is
also assured that the process will consistently produce the
expected results.
4
5. INTRODUCTION:
There are 3 key points to from this definition:
• The evidence must be documented.
• Valiodation applies to several aspects of manufacturing,
including process development, materials, personal and
equipment.
• It should demonstrate that the system does what is
expoected of it.
5
6. NEED FOR VALIDATION:
• Customer satisfaction
• Customer mandated.
• Product liability.
• Control production cost
• Development of new generation.
• Safety.
6
7. TYPES OF PROCESS VALIDATION:
The guidelines on general principles of process validation
mentions four types of validation:
A) Prospective validation (or premarket validation)
B) Retrospective validation
C) Concurrent validation
D) Revalidation
7
8. PROSPECTIVE VALIDATION:
• This is performed for all new equipment, product and
processes.
• It is a proactive approach of documenting of design,
specification and performance before the system is
operational.
• This is the most defendable type of validation.
8
9. RETROSPECTIVE VALIDATION:
• Retrospective validation is used for facilities, processes,
and process controls in operation use that have not
undergone a formally documented validation process.
• Validation of these facilities, processes, and process
controls is possible using historical data to provide the
necessary documentary evidence.
• Therefore, this type of validation is only acceptable for
well-established processes and will be inappropriate where
there have been recent changes in the composition of
product, operating processes, or equipment.
• This approach is rarely been used today because it’s very
unlikely that any existing product hasn’t been subjected to
the Prospective validation process. It is used only for the
audit of a validated process. 9
10. CONCURRENT VALIDATION:
• Concurrent validation is used for establishing documented
evidence that a facility and processes do what they purport
to do, based on information generated during actual
imputation of the process.
• This approach involves monitoring of critical processing
steps and end product testing of current production, to
show that the manufacturing process is in a state of
control.
10
11. REVALIDATION:
• Revalidation means repeating the original validation effort
or any part of it, and includes investigative review of
existing performance data. This approach is essential to
maintain the validated status of the plant, equipment,
manufacturing processes and computer systems. Possible
reasons for starting the revalidation process include:
• The transfer of a product from one plant to another.
• Changes to the product, the plant, the manufacturing
process, the cleaning process, or other changes that could
affect product quality.
11
12. REVALIDATION:
• The necessity of periodic checking of the validation
results.
• Significant (usually order of magnitude) increase or
decrease in batch size.
• Sequential batches that fail to meet product and process
specifications.
• The scope of revalidation procedures depends on the
extent of the changes and the effect upon the product.
12
13. SCOPE OF VALIDATION:
• Validation requires an appropriate and sufficient
infrastructure including:–organization, documentation,
personnel and finances.
• Involvement of management and quality assurance
personnel
• Personnel with appropriate qualifications and experience
• Extensive preparation and planning before validation is
performed.
• A specific programme for validation activities in place.
13
14. SCOPE OF VALIDATION:
• Validation done in a structured way according to
documentation including procedures and protocols.
• Validation should be performed:–for new premises,
equipment, utilities and systems, and processes and
procedures;–at periodic intervals; and–when major
changes have been made.
• Validation in accordance with written protocols.
14
15. SCOPE OF VALIDATION:
15
• A written report on the outcome to be produced.
• Validation over a period of time, e.g.–at least three
consecutive batches (full production scale) to demonstrate
consistency.
• Process, materials and equipment to prove consistent yield
of a product of the required quality.
• Manufacturers to identify what validation work is needed
• Significant changes (facilities, equipment, processes) -
should be validated
• •Risk assessment approach used to determine the scope
and extent of validation needed.
16. REFERENCE:
16
• Fundamental of quality assurance techniques…by Ramesh
Sawant and Sandip Hapse, First edition Dec 2011, Career
publications.
• Pharmaceutical Quality Assurance...by Manohar Potdar,
Second edition Dec 2007,Nirali Prakashan.
• IJRPC 2011` An overview of pharmaceutical validation:
quality assurance view point’ by Nandhakumar et al.
• IJPR Review Article’ An Overview of pharmaceutical
Validation and Process Controls in Drug Development’
Elsie Jatto and Augustine O. Okhamafe.